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European E&L Strategic DirectorHall Analytical
Director Senior Expert Nonclinical SafetyBayer AG
Managing DirectorMaven E&L Ltd.
President Analytical ServicesAspen Research Corporation
ToxicologistRisk Science Consortium and Former FDA
Managing Partner & Toxicology ExpertD&B ChemTox, LLC
Managing Partner &ToxicologistD&B ChemTox, LLC
Senior Principal Research ScientistAbbVie, Inc
Partner & CTOSAXOCON
Staff Scientist, Analytical Sciences - Inhalation Product DevelopmentAstraZeneca
Senior Director, Science, Regulation & PolicyFaegre Drinker (Member of ELSIE)
Principal Scientific LiaisonUnited States Pharmacopeia (USP)
Principal ConsultantFeinberg Norwood & Associates Pharma Consulting
Senior Pharmaceutical Products Manager, Pharma and Biopharma Marketing - Chromatography & Mass Spectrometry DivisionThermo Fisher Scientific
Product Marketing Manager GC OrbitrapThermo Fisher Scientific
Application EngineerAgilent Technologies
Principal Scientist, SLSGlobal Regulatory and Validation Consulting group, Pall Biotech
Dy DirectorSerum Institute of India
European E&L Strategic Director
Dr Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and Technical thought leadership activities.
Dr. Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written several papers and publications and is the inventor of 2 patents.
Dr. Andrew Feilden has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
Director Senior Expert Nonclinical Safety
Dr. Clemens Guenther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany, as scientist specialized for development of Transdermal Therapeutic Systems and topical Dermatological. In 2000 he became Head of Animal Pharmacokinetics within the Function of Pharmacokinetics. From 2007 to 2013, Dr. Guenther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.
After integration of the Intendis R&D platform into the Bayer Pharma R&D structure in July 2013, Dr. Guenther took over a new role as Director Nonclinical Safety Consumer Health within the Division of Bayer Pharmaceuticals. In June 2020, he became Senior Expert Nonclinical Safety within Bayer AG, R&D Pharmaceuticals. In this actual position he is still involved in the development of new chemical entities including small molecules and biological as well as the life cycle management of marketed prescribed and OTC drug products.
Meanwhile Dr. Guenther gained more than 30 years’ experience in drug development from drug discovery to post-marketing, and has successfully achieved regulatory approvals of drug products in various indications
Maven E&L Ltd.
Mr. Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s. Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L).
Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.
Mr. Creasey has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE.
Currently Mr. Creasey is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.
President Analytical Services
Aspen Research Corporation
Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. Dr. Roger Pearson is an industry recognized expert in Food Contact and Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.
Risk Science Consortium and Former FDA
Mr. Ron Brown is an internationally known toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Mr. Brown was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations. At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee.
Prior to his position at the US FDA, Mr. Brown served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Mr. Brown is highly sought after as a speaker at E&L meetings in the US, Europe, and Asia and he serves on the Advisory Boards of a number of major E&L meetings.
Managing Partner & Toxicology Expert
D&B ChemTox, LLC
Dr. William Beierschmitt received his B.S. in Biology from Mount Saint Mary’s University, and his Ph.D. in Toxicology from the University of Maryland. After completing post-doctoral work at the University of Connecticut Toxicology Program, he began a
career in Pfizer’s Drug Safety Research and Development department in Groton, Connecticut. While at Pfizer, Bill founded and lead a group that provided
chemical risk assessment
support to all the company’s global research and develop sites and manufacturing facilities. Currently, Dr. Bill is a Managing Partner and Toxicologist at D&B ChemTox, LLC, a consulting group specializing in the
safety qualification of chemical impurities in pharmaceutical products.
Dr. Beierschmitt is a full member of both the Society of Toxicology and the American College of Toxicology, a Diplomate of the American Board of Toxicology, and a Fellow of the Academy of Toxicological Sciences. He is a recognized expert in the evaluation and qualification of leachables andextractables (L&E) in drug products. He was a founding member of both the Product Quality Research Institute(PQRI) L&E work group developing best practice recommendations for Parenteral and Ophthalmic DrugProducts (PODP), and the Extractables and LeachablesSafety Information Exchange (ELSIE) database initiative. Dr. William Beierschmitt currently serves as an Expert Panel member for USP reviewing and updating Biocompatibility Chapters <87>,<88>, and <1031>.
Managing Partner &Toxicologist
Douglas (Doug) Ball obtained his BS and MS in Biology from St. John’s University, Jamaica, NY and is board certified in general toxicology (DABT). Doug is a full member of the American
College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President,
Vice President and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT).
He was previously employed as a toxicologist at Sandoz (now Novartis), Boehringer
Ingelheim, and Pfizer. Over the past 40 years, he has assumed various project and
regulatory strategy roles and is currently a Managing Partner and Toxicologist at D&B
Doug is a recognized expert in the evaluation and qualification of leachables and
extractables (L&E) in drug products. He co-chaired a Product Quality Research Institute
(PQRI) L&E work group and co-authored the PQRI Best Practices Recommendations for
Evaluation of L&E in Orally Inhaled and Nasal Drug Products (OINDP, 2006) and soon
to be released best practice recommendations for Parenteral and Ophthalmic Drug
Products (PODP). Doug is an Expert Panel member for USP <381> Elastomeric
Closures for Injection and Biocompatibility <87> and <88>, was the Pharmaceutical
Research Manufacturers Association (PhRMA) Deputy Topic Lead for the International
Conference on Harmonisation (ICH) Expert Working Group (EWG) and Implementation
Working Group (IWG) for Elemental Impurities (Q3D). Douglas Ball was a Chair and Board
member of the Extractables and Leachables Safety Information Exchange (ELSIE).
Senior Principal Research Scientist
Greg Erexson, PhD, DABT, ATS, FRSB, ERT is a Senior Principal Research Scientist at AbbVie, Inc. in North Chicago, IL (2013-present) in Occupational and Environmental Toxicology, Preclinical Safety. He was at Abbott Laboratories, North Chicago, IL in 2012 prior to the split of Abbott into two separate companies, Abbott and AbbVie on January 2, 2013. Dr. Greg was at Baxter Healthcare in Round Lake, IL from 2006 to 2012 as aRegulatory Toxicologist primarily working in the areas of risk assessment of E&L and extraneous matter.He received both his PhD and Master’s degrees from North Carolina State University, Raleigh, NC in Toxicology and Comparative Biomedical Sciences.Dr. Greg received his Bachelor’s degree in Biology from the University of North Carolina, Chapel Hill, NC. From 2000 to 2006, He was a Manager-Study Direction at Covance Laboratories, Inc. in Vienna, VA. He was board-certified in general toxicology by the American Board of Toxicology (DABT) in 1999 and recertified in 2004, 2009 and 2014. Dr. Erexson was inducted as a Fellow in the Academy of Toxicological Sciences (ATS) in 2014 and as a Fellow in the Royal Society of Biology (FRSB)-UK in 2015. He became a European Registered Toxicologist (ERT) in 2015. He has been involved with the Extractables and Leachables Information Safety Exchange (ELSIE) consortium essentially since its inception in 2007. He is currently the chair of the ELSIE Board of Directors. He was also a member of the USP Toxicology Expert Committeefrom 2010 to 2015, former president of the Midwest Regional Society of Toxicologyand the Medical Device and Combination Product Specialty Section.Dr. Greg Erexson has authored over 90 peer-reviewed scientific publications.
Partner & CTO
Dr. Carsten Senholt is a Partner and Chief Technical Officer at Saxocon A/S. He has completed DVM from Royal Veterinary and Agricultural University and MSc in Applied Toxicology from University of Surrey, UK. Dr. Carsten has 20 years of industrial experience responsible for risk assessment of extractable and leachables from materials used in delivery systems.
2 years as CTO and principle toxicologist in SAXOCON.
Dr. Carsten Senholt served 15 years as nominee by Danish Standard as external expert in ISO/TC 194 for the ISO 10993 series for biocompatibility of medical devices.
Staff Scientist, Analytical Sciences - Inhalation Product Development
Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on trace analysis, extractables and leachables (E&L). He began E&L career extracting and analyzing flavor compounds from soy protein. In 2005 he began to work with pMDI container closure systems. Currently he manages the E&L activities at RTP and support other R&D groups within AstraZeneca. Testing for nitrosamines in drug products and packaging is at present an area of focus.
A member of the Materials Working Group within ELSIE and Knowledge Base sub-team Dr. Atish have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and nitrosamine testing on container closure systems. Dr. Atish Sen has completed Ph.D. in Physics from the University of Wyoming.
Senior Director, Science, Regulation & Policy
Faegre Drinker (Member of ELSIE)
Dr. Lee M. Nagao, Ph.D., is a Senior Director of Science, Regulation and Policy at the law firm of Faegre, Drinker, Biddle and Reath, LLP, and is a member of the Firm’s Life Sciences Consortium Management and Regulatory Affairs Practice Group. The Group works extensively with pharmaceutical, biopharmaceutical and medical device companies on a range of scientific and regulatory collaborations and provides strategic and regulatory guidance to individual life sciences companies. Dr. Lee plays a lead role serving scientific and regulatory consortia including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). Dr. Nagao has extensively published and presented on extractables and leachables, materials quality topics, and other aspects of pharmaceutical development. Dr. Lee Nagao has represented various industry groups before regulatory and scientific agencies and organizations in the US, Europe and Asia, including the FDA, EMA, China NIFDC, Chinese Pharmacopoeia, ANVISA, Taiwan CDE, Japan PMDA, and USP.
Principal Scientific Liaison
United States Pharmacopeia (USP)
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Desmond Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA.
Feinberg Norwood & Associates Pharma Consulting
Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. In 2019, SCIO Analytical became Feinberg Norwood & Associates Pharma Consulting. In addition, he is Senior Independent Consultant to Smithers Rapra and Pira. Prior to SCIO Analytical, he was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis. In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development.
Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP) and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). From 2010-2020, he served as a member of the USP Expert Committee on Packagingand Distribution where he has chaired the subcommittee on extractables and leachables. Dr. Daniel Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013).
Senior Pharmaceutical Products Manager, Pharma and Biopharma Marketing - Chromatography & Mass Spectrometry Division
Thermo Fisher Scientific
Kate Comstock is a Senior Pharmaceutical Products Manager inPharma and BiopharmaMarketing at Thermo Fisher Scientific, Life Sciences Mass Spectrometry Division in San Jose, CA., USA.Kate joined Thermo in 2010 to support new MS product research &development,small molecule structure analysis applications inthe pharmaceutical industry, and extractables & leachables analysisusing high resolution mass spectrometry. She also conducts both hardware and software training.
Prior to Thermo, Kate was a research scientist at the core mass spectrometry facilityof Roche Pharmaceutical, Palo Alto, California for 20 years, where she supported drug R&D using a variety of high resolution LCMS systemsfor small molecule API impurity ID and structure elucidation, as well as counterfeit drug identification.
Kate Comstock has a BS in chemistry from Heibei Normal University, China; MS in Pharmaceutical Sciences fromPeking University School of Pharmaceutical Sciences, and MS in Chemistry from San Jose State University, CA, USA.
Product Marketing Manager GC Orbitrap
Dominic Roberts has been closely involved with the Thermo Scientific GC Orbitrap MS since its launch in 2015. He started at Thermo Fisher Scientific as a Senior Applications Specialist for the product and is currently the GC Orbitrap MS Marketing Manager. Dominic is an experienced analytical chemist and mass spectrometrist with more than 20 years of experience using state-of-the-art analytical systems. Dominic Roberts has worked in both a regulatory and industrial environment with GC–MS and LC–MS systems to investigate a variety of chemicals in food, biological, and environmental samples.
After completing M.Sc. (Hons.) in Chemistry at Punjab University, Chander Mani started his career at Panacea Biotec in Analytical & Bioanalytical department of new drug discovery research and developed several methods for analytical and bioanalytical, and ADME/DMPK related studies. He also worked for several LC-MS based methods for the analysis of textiles and environmental analytes of interests during his stay in Bureau Veritas. For the past more than 7 years at Agilent, Chander has been actively involved in providing LC-MS based application support to pharmaceuticals, BA/BE, food safety and environmental based applications in his various roles. Chander has been extensively engaged in Nitrosamine application development
Principal Scientist, SLS
Global Regulatory and Validation Consulting group, Pall Biotech
Sudhakar Nagaraj has been in Pharmaceutical industry for over 18 years and has held positions of increasing responsibility in Pharmaceutical QC/QA, R&D, Validations and Regulatory affairs. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization and has been involved in updating Pall’s technical support portfolios with rapidly evolving end-user and regulatory requirements, to streamline customer selection, adoption and successful regulatory approval of Pall technologies.
Currently, he is part of SLS Global Regulatory and Validation consulting team which is focused to provide streamlined technical guidance and scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. Examples of customer-focused solutions include application risk assessments for adoption of Pall technologies, development of improved Extractables and Leachables validation service, toxicology service, high risk filter validation (SOAR) service, customer-aligned change management model, online access to controlled filter integrity test values, standardized material compatibility information, Biotech material resins repository, BPOG & USP extractables datasets and QbD/QRM support packages.
Sudhakar Nagaraj is an active PDA India chapter member andrepresents Pall in Asia. He has completed post-graduation in Microbiology.
Serum Institute of India